中药制造全过程的品质传递控制与一致性评价研究进展

Research progress on quality transfer control and consistency evaluation in whole process of traditional Chinese medicine manufacturing

中药品质的一致性是保障临床疗效一致性的关键,也是保证中药安全性、可控性的前提和基础。中药制剂的品质形成过程非常复杂,涉及药材、饮片、中间体、制剂多个传递环节。将中药的高品质属性顺利传递到临床,关键在于建立中药制造各环节产品的品质一致性整体评价体系,并结合评价技术进行中药制造全过程品质传递控制。现有的中药品质一致性评价体系多以化学品质评价为主,不能全面表征中药品质,目前对于中药制造过程的控制手段也主要依靠对中间体或终端产品的离线检测,难以及时、有效地获取中药制造过程的变化。因此,以中药临床价值为导向,对中药制造全过程的品质传递控制与一致性评价研究进行综述,为保证中药产品的高品质属性与临床疗效提供参考。

The consistency of the quality of traditional Chinese medicine(TCM)is the key to ensure the consistency of clinical efficacy,and also the premise and basis to ensure the safety and controllability of TCM.The quality formation process of TCM preparation is very complicated and involves multiple transfer links,including Chinese medicinal materials,Chinese herbal decoction pieces,intermediates and Chinese medicine preparations.The key to successfully transfer the high-quality attribute of TCM to the clinic is to establish an overall evaluation system for the quality consistency of products in all aspects of TCM manufacturing,and to combine the evaluation technology to control the quality transfer in the whole process of TCM manufacturing.The existing consistency evaluation system of TCM quality is mainly based on chemical quality evaluation,which cannot fully characterize the quality of TCM.At present,the control methods of the manufacturing process of TCM mainly rely on the off-line detection of intermediates or terminal products,which is difficult to obtain the changes in the manufacturing process of TCM in a timely and effective manner.Therefore,based on the clinical value of TCM,the quality delivery control and consistency evaluation of the whole process of TCM manufacturing were reviewed,so as to provide reference for ensuring the high-quality attribute and clinical efficacy of TCM products.